DICLOFENAC SODIUM
- Product NDC
- 68462-355
- 11-digit product format
- 684620355
- Labeler code
- 68462
- Product ID
- 68462-355_6c2982e4-c4a4-4985-82d1-e418c5e055e1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diclofenac sodium
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- GLENMARK PHARMACEUTICALS INC., USA
- Application
- ANDA208301
- Marketing category
- ANDA
- Marketing start
- 2016-09-13
- Substance
- DICLOFENAC SODIUM
- Active strength
- 30 mg/g
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DICLOFENAC SODIUM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 30 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855642 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-355-94 | DICLOFENAC SODIUM | 1 in 1 CARTON | GEL | 1 | | 8 |
| 68462-355-94 | DICLOFENAC SODIUM | 100 g in 1 TUBE | GEL | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-355 | DICLOFENAC SODIUM GEL [GLENMARK PHARMACEUTICALS INC., USA] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250121_dab3ae60-0135-43b3-a1d0-8752720af82a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68462-355-94 | 68462035594 | 1 TUBE in 1 CARTON (68462-355-94) / 100 g in 1 TUBE | 1 tube | 2016-09-13 | 0000-00-00 | No | No | Current |